Evelo Biosciences(US:EVLO)2019-11-09 06:59Financial Data and Key Metrics Changes - The company reported positive interim clinical data for EDP1815, indicating a mean reduction in lesion severity score of 15% at day 28 and a continued reduction to 24% at day 42 post-dosing, suggesting a sustained clinical effect [19][23] - The mean reduction in PASI score was 16% at day 28, improving to 21% at day 42, with maximum observed reductions of 80% and 61% respectively [23][36] Business Line Data and Key Metrics Changes - EDP1815 is being developed as a potential oral therapy for mild to moderate psoriasis, with a focus on safety and tolerability as competitive advantages [8][9] - The high dose cohort showed consistent results with the low dose cohort, indicating a possible dose response [11][19] Market Data and Key Metrics Changes - Chronic inflammation affects 1 in 7 people globally, with significant unmet needs in treating mild to moderate psoriasis, where many patients are dissatisfied with current treatment options [11][12] - The company aims to address the needs of millions of patients with effective, safe, and affordable oral therapies [7][12] Company Strategy and Development Direction - The company plans to advance EDP1815 into Phase II trials early next year, focusing on its potential as a midline therapy to defer the use of injectable biologics [24][34] - The strategy includes expanding the application of its platform to other inflammatory diseases and potentially to neuroinflammation and metabolic diseases [25][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of EDP1815 based on positive interim data and the unique approach of targeting the small intestinal axis [6][36] - The company anticipates a catalyst-rich 2020 with expected data from various clinical stage programs [35] Other Important Information - The company has completed enrollment for a cohort of patients with microsatellite stable colorectal carcinoma and observed extended stable disease in several patients [66][68] - The new formulation of EDP1815 shows a 30-fold improvement in activity based on preclinical data, which is expected to enhance efficacy in clinical trials [38][41] Q&A Session Summary Question: How does the data reported today frame expectations for the next-generation formulation? - Management indicated that the new formulation will be compared with the existing formulation in Phase II studies, with optimism based on preclinical data showing significant improvements [38] Question: Will there be an active comparator study for EDP1815? - Management stated that while the focus is currently on demonstrating clinical benefits, active comparators will be introduced at appropriate stages of development [39] Question: What kind of expectation should be set for the new formulation's data? - Management expects the new formulation to provide greater depth of responses and quicker onset based on preclinical findings [41][44] Question: How does the psoriasis data inform the approach to atopic dermatitis? - Management emphasized the relevance of the small intestinal axis across inflammatory diseases, suggesting predictive value for atopic dermatitis studies [51][54] Question: Will dosing be extended from daily to weekly? - Management clarified that while the therapy is intended to be daily, it is forgiving, allowing for missed doses without losing clinical effect [57]